Schizotypal Personality Disorder Clinical Trial
Official title:
The Dopaminergic System in Schizotypal Personality Disorder: Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder
NCT number | NCT00252044 |
Other study ID # | 7609-028 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | November 9, 2005 |
Last updated | November 17, 2005 |
Start date | October 2000 |
Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1)
working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the
AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis
by drug administration of 0.3 mg of oral pergolide interaction for performance on the
cognitive tasks, with the schizotypal personality disorder group demonstrating significantly
improved peformance compared to the other personality disorder group after pergolide
compared with placebo.
Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects
receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed
by pergolide for four weeks.
Status | Recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: DSM-IV criteria for Schizotypal Personality Disorder (or meets full
criteria bar one) or another personality disorder and shows impairment on markers of
cognitive functioning. Medically healthy, not abusing drugs or alcohol, is at least two
weeks medication-free and does not have significant neurological disease. Exclusion Criteria: DSM-IV or RDC criteria for Schizophrenia or any Schizophrenia-related psychotic disorder or for Bipolar Disorder. Any other Axis I disorders must be transient and preceded by the personality disorder diagnosis, which should be primarily responsible for subject’s functional impairment. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Bronx VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance on tests of sustained attention, episodic memory and working memory at baseline and after 2, 4, 6 and 8 weeks on the study medication | |||
Secondary | Hamilton Depression Rating Scale, Positive and Negative Symptom Scale and Clinical Global Impression scale at baseline and then weekly through the end of the trial |
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